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NCT00309699 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
NCT00309699: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00309699 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 493 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00309699, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.
Interventions
- DRUG Placebo
- DRUG Quetiapine
- DRUG Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
What the finished NCT00309699 record still lists
NCT00309699 is an interventional study that assigns participants to a tested intervention. The registered 493 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00309699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00309699 about?
NCT00309699 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder". The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of pal...
What is the current status of trial NCT00309699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2006-04. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00309699?
The interventions under investigation include: Placebo (DRUG), Quetiapine (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00309699?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00309699's enrollment target sits among peer trials
493 779th of 2000 higher than 1,221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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